Clinical development of CT-P6 in HER2 positive breast cancer

ABSTRACT

Introduction: CT-P6 (trastuzumab-pkrb, Herzuma) is a trastuzumab biosimilar approved for use in HER2 positive breast cancer and HER2 positive gastric cancer. CT-P6 has been shown to exhibit similar safety and efficacy profiles to its reference product, trastuzumab. Preclinical and clinical studies have been performed to prove equivalence between CT-P6 and the trastuzumab originator.

Areas Covered: In this review, we examine the evidence comparing CT-P6 with its reference product, trastuzumab. Both monoclonal antibodies function to target cells that overexpress HER2 on the cell surface. Preclinical pharmacologic modeling of CT-P6 shows a similar mechanism of action to trastuzumab, similar pharmacologic properties and a phase I trial in healthy volunteers showed similar pharmacokinetics. A multicenter phase III randomized clinical trial in patients with early breast cancer showed equivalent safety and efficacy between CT-P6 and trastuzumab. One-year follow-up of patients showed identical rates of cardiotoxicity.

Expert Opinion: Preclinical and clinical studies showed CT-P6 pharmacologic profile, safety and efficacy are equivalent to trastuzumab. As such, it is a safe and effective alternative for use in patients with HER2 positive breast cancer and gastric cancer. Its implementation into clinical practice can potentially increase patient access and help financially alleviate overburdened health-care systems.

KEYWORDS:

• Breast neoplasm
• HER2
• trastuzumab
• biosimilar

Article highlights

• CT-P6 is a trastuzumab biosimilar approved for the treatment of HER2 positive breast cancer and HER2 positive gastric cancer

• Preclinical and clinical studies showed equivalence between CT-P6 and the reference trastuzumab originator in breast cancer

• CT-P6 and the reference trastuzumab share the same mechanisms of action against cancer cells

• Phase I and phase III clinical trials showed similar pharmacologic properties for CT-P6 and reference trastuzumab

• A phase III randomized clinical trial showed similar safety and efficacy in patients with early breast cancer treated with either CT-P6 or reference trastuzumab, in combination with docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide in the neoadjuvant setting.

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Declaration of interest

J Stebbing, the Editor-in-Chief of Oncogene, sat on SABs for Celltrion, Singapore Biotech, Vor Biopharma, TLC Biopharmaceuticals, and Benevolent AI, has consulted with Lansdowne partners, Vitruvian and Social Impact Capital and he Chairs the Board of Directors for BB Biotech Healthcare Trust and Xerion Healthcare. FJ Esteva has served as consultant for Celltrion, Genentech/Roche and Novartis. His research has been supported by the Breast Cancer Research Foundation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One of the peer reviewers on this paper has received lecture fees and honoraria for participation on advisory boards from Eli Lilly, Roche, Genentech and Novartis, and research grants to the institution from Roche, Genentech. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.